Subthreshold SCS or BMT

Launched by MOENS MAARTEN · Dec 22, 2021

Keywords

ClinConnect Summary

This clinical trial is looking to find out whether a treatment called subthreshold spinal cord stimulation (SCS) is more effective than the best medical treatment (BMT) for patients suffering from a condition known as Persistent Spinal Pain Syndrome Type II (PSPS-T2). The main goal is to see if patients receiving subthreshold SCS experience better overall improvements in their pain and quality of life after six months. Additionally, the study will explore if this treatment helps patients manage their pain better, return to work, and reduce their need for pain medication.

To participate in this trial, individuals must be at least 18 years old and have experienced chronic pain from PSPS-T2 for at least six months, with a pain level of 4 or higher on a scale of 0 to 10. They should also be eligible for the subthreshold SCS treatment. Participants will be required to attend study visits and follow the study guidelines closely. It's important to know that those with certain medical conditions or psychiatric disorders may not be eligible for this trial. If you're interested, this study could provide valuable insights into new treatment options for managing chronic pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Persistent Spinal Pain Syndrome Type II (PSPS-T2)
• • Chronic pain as a result of PSPS-T2 that exists for at least 6 months with a pain intensity of at least 4/10 on the Numeric Rating Scale, refractory to conservative treatment.
• • PSPS-T2 patients eligible for subthreshold SCS
• • Age \> 18 years
• • Patient has been informed of the study procedures and has given written informed consent
• • Patient willing to comply with study protocol including attending the study visits
• Exclusion Criteria:
• • Expected inability of patients to receive or properly operate the spinal cord stimulation system
• • Evidence of an active psychiatric disorder
• • Suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma).
• • Pregnancy